Pregnancy Related
Conditions
Brief summary
This study aims to explore outcomes of waterbirth in comparison to conventional land birth for low-risk healthy women and neonates in a hospital setting in Milwaukee, WI. This study hypothesizes that women who labor and birth in water will use less pain medication, have a shorter labor, will be more likely to initiate breastfeeding prior to discharge, will not experience more negative outcomes, and will experience greater satisfaction than women who labor and birth on land.
Detailed description
Women eligible for a waterbirth will be randomized (2:1) to either waterbirth or land birth at the beginning of the third trimester (25 weeks 0 days to 34 weeks 0 days gestation). The investigators recognize that some women will risk-out or opt-out because of the unpredictability of labor and birth. The goal is that approximately 50% of enrolled waterbirth participants give birth in water. Additionally, the investigators aim to approach the majority of patients eligible for waterbirth with the understanding that some women will not want to participate in a research study. Please note that given the variable nature of birth, once a woman is randomized and enrolled to either group, an intention to treat model will be used for analysis. Following birth, women will be asked to complete a validated questionnaire to evaluate maternal satisfaction prior to discharge. Other data will be collected from our electronic medical record or 4-8 weeks postpartum.
Interventions
OTHERWater Birth
The water birth group will use a tub of a water to labor and give birth.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Women are randomized 1:2 land birth to waterbirth.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Prenatal low-risk, healthy, adult women (greater than or equal to 18 years of age), including: 1. Able to speak and understand English 2. Women with a singleton gestation 3. Able to ambulate with no mobility restrictions (i.e., no difficulty getting from seated to standing) 4. Less than class III obesity (BMI \<40kg/m squared) at initiation of prenatal care 5. No active infections such as HIV, Hepatitis B, Hepatitis C, herpes simplex virus outbreak (on prophylaxis acceptable), group B strep positive is acceptable 6. No pre-existing medical conditions such as: heart disease, uncontrolled asthma, diabetes of any type, chronic hypertension, or other condition that requires continuous observation and/or activity restrictions 7. No high-risk pregnancy conditions: including preeclampsia, gestational hypertension, preterm gestation, multiple gestation, substance abuse, placental abruption or other unexplained vaginal bleeding, previous cesarean section, suspected fetal macrosomia (\>4500gm) or intrauterine growth restrictions (\<10th percentile), or other condition that requires continuous observation and/or activity restrictions Labor inclusion criteria: 8. Greater than 37 weeks and less than 42 completed weeks gestation in vertex presentation 9. Not hypertensive or febrile (two blood pressures 140/90 four hours apart; two fevers of over 100.4 one hour apart) 10. Category 1 fetal heart tones (obtained on a 20-minute admission external fetal monitor strip) 11. Amniotic sac may be intact or ruptured. If ruptured, amniotic fluid must be clear.
Exclusion criteria
* Women will be excluded from the study if they do not meet above inclusion criteria or they will be further excluded under the following circumstances: 1. Known need for cesarean section 2. Participant may be excluded from the study at any time at the discretion of the birth attendant (reason for study exclusion will be documented but will remain in the study group previously selected based on intention to treat).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Using Intravenous Narcotic Analgesia and Epidural Anesthesia | Time of admission to birth of the baby | The number of women in the waterbirth cohort who use IV narcotic and epidural anesthesia compared with the land birth cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time of Labor Duration | Time of labor onset to time of birth | The median time of labor duration (1st stage onset of strong regular contractions resulting in cervical change, 2nd stage pushing and birth of the neonate, 3rd stage delivery of the placenta) of women in the waterbirth cohort will be compared to the land birth cohort. |
| United States Birth Satisfaction Scale-Revised (US-BSS-R) Score | Up to 72 hours post delivery | The US-BSS-R is a 10 question scale using a 5 point Likert scale with answers ranging from "strongly agree" to "strongly disagree". The overall US-BSS-R total birth satisfaction score ranging from 0-40 (least birth satisfaction - most birth satisfaction). Women in the waterbirth cohort will be compared to those in the land birth cohort for overall US-BSS-R score. |
| Number of Reported Maternal Adverse Outcomes | During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth) | The number of women in the waterbirth cohort with reported adverse maternal obstetric outcomes will be compared to the land birth cohort. |
| Number of Patients Breastfeeding | Measured from birth (immediate) through discharge from hospital (24-48 hours) | The number of women in the waterbirth cohort who initiate immediately after the birth breastfeeding will be compared to those in the land birth cohort. |
| Number of Neonatal Adverse Outcomes | Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life) | The number of patients with neonates in the waterbirth cohort with reported adverse birth outcomes will be compared to patients with neonates in the land birth cohort. |
| Number of Patients With Neonates With Instrumental and Cesarean Deliveries | Time of labor to time of delivery | The number of patients with neonates in the waterbirth cohort with instrumental and cesarean deliveries will be compared to patients with neonates in the land birth cohort. |
| Number of Patients With Skin-to-skin Contact | Measured from time of birth (hour/minute) to time of skin-to-skin contact initiation (in number of minutes) up to 60 minutes of life. | The number of patients with neonates in the waterbirth cohort with skin-to-skin contact will be compared with patients with neonates in the land birth cohort. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmily Malloy, CNM, APNP
emily.malloy@aah.org
Participant flow
Recruitment details
IRB-approved recruitment flyers were placed in clinic lobbies to increase interest during prenatal care visits. During prenatal care visits between 25-34 weeks' gestation, pregnant people who met inclusion criterial were offered voluntary participation after informed consent.
Pre-assignment details
Upon enrollment, participants were randomized to either the waterbirth group or land birth group using a computer-generated allocation sequence. When participants presented to the labor and delivery until, both groups were reassessed for eligibility. If they remained eligible, those in the waterbirth group received routine care, all available pain relief options, with the additional option of giving birth in the water. Land birth were not given option of birth in the water.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 28.8 years |
| Race/Ethnicity, Customized Race/Ethnicity Black | 32 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 37 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 124 |
| other Total, other adverse events | 5 / 62 | 12 / 124 |
| serious Total, serious adverse events | 0 / 62 | 0 / 124 |
Outcome results
None listed